膦甲酸钠治疗重度慢性乙型肝炎的临床研究  

Foscarnet sodium for treatment in patients with severe chronic hepatitis B

作　　者：于岩岩[1] 张大志[2] 缪晓辉[3] 朱传琳[4] 周霞秋[5] 于浩[6] 斯崇文[1] 

机构地区：[1]北京大学第一医院感染科,100034 [2]重庆医科大学附属第二医院 [3]第二军医大学长征医院 [4]解放军第三○二医院 [5]上海瑞金医院 [6]南京医科大学流行病与生物统计学教研室

出　　处：《中华肝脏病杂志》2006年第11期814-816,共3页Chinese Journal of Hepatology

摘　　要：目的探讨膦甲酸治疗重度慢性乙型病毒性肝炎的疗效和安全性。方法208例患者按1：1随机分为治疗组和对照组,治疗组109例,膦甲酸钠注射液3．0g/250ml静脉点滴．每日2次,疗程4周。对照组为99例,等渗盐水250ml静脉点滴,每日2次,疗程4周,随访24周。结果用药4周时,治疗组和对照组的HBV DNA阴转率分别为12．8%和7．1%,随访24周时分别为5．5%和3．0%,差异无统计学意义。治疗组治疗后HBV DNA≤10~5拷贝/ml在用药4周、停药随访24周分别为64．2%(70/109)和40．4%(44/109),对照组分别为30．3%(30/99)和22．2%(22/99),x^2值分别为24．466和8．962,P值均＜0．01,差异有统计学意义。HBeAg转阴率用药4周、随访24周,治疗组分别为17．3% (14/81)、22．0%(11/50)；对照组分别为5．8%(5/87)和5．4%(4/74),P值分别为0．026 6和0．009 6,差异有统计学意义。HBeAg血清转换率用药4周、随访24周,治疗组分别为12．7%(10/79)和16．7%(8/48)；对照组分别为3．7% (3/82)和1．5%(1/69),P值分别为0．044 5和0．003 4。差异有统计学意义。治疗结束时,应答率分别为60．6%和21．2%,Z=5．668 3,P＜0．05。结论膦甲酸钠注射液治疗重度慢性乙型病毒性肝炎有较好的疗效和安全性。Objective To investigate the effectiveness of foscarnet sodium in the treatment of severe chronic hepatitis B. Methods Two hundred and eight patients were enrolled in a multicenter, double-blind, controlled study. The patients received foscarnet sodium （foscarnet group） or saline （control group） injections for 4 weeks, and were then followed for 24 weeks. Results HBV DNA negative rate was 12.8% in the foscarnet group and 7.1% in the control group at the end of treatment; and it was 5.5% and 3.0% at the end of the follow-up period respectively （P 〉 0.05）. The rate of HBV DNA decrease of more than 2 log copies/ml was 53.2% in the foscarnet group and 16.2% in the control group at the end of treatment, and 23.9% and 8.1% （P 〈 0.01） respectively at the end of the follow-up period. The rate of HBV DNA〈10^5 copies/ml was 64.2% and 30.3% at week 4 in the two groups respectively, and 40.4% and 22.2% （P 〈 0.01） at the end of the follow-up period. HBeAg negative rate was 17.3% and 5.8% at the end of the treatment, and 22% and 5.4% at the end of the follow-up period （P 〈 0.01）. The rate of HBeAg seroconversion was 12.7% and 3.7% at week 4, and 16.7% and 1.5% at the end of the follow-up period. Response rate was 60.6% and 21.2% at the end of week 4 （P 〈 0.05）. Conclusion Foscarnet sodium injection has a good effect on severe chronic hepatitis B patients and it is safe to use on them.

关 键 词：肝炎 乙型 慢性 临床试验 膦甲酸钠 

分 类 号：R512.62[医药卫生—内科学]